Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542631
• Other study ID #: VP-00525
• Secondary ID: 2015-003761-28
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2018
• Source: Calibra Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

Description:

Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin dosing and followed for a 44-week intervention period. Patients will have both basal and bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44, patients will crossover to the alternate bolus insulin delivery device for 4 weeks and complete a patient preference survey at week 48.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of T2DM

• Treated with basal insulin for = 6 months, with current dose stable for = 6 weeks of = 0.3 U/kg/day, with or without anti-hyperglycemic agents and in whom the Investigator feels advancement from basal to basal and bolus therapy is needed for the patient

• A1C 7.5-11.0% by central lab value at screening visit

• Already perform self-monitoring of blood glucose (SMBG) and willing to test blood glucose (BG) over the course of the study

• Body Mass Index of = 40 kg/m2

Exclusion Criteria:

• Currently on or has been treated in the past year with insulin regimens that include bolus insulins except the need for insulins in the settings of acute illness or hospitalization

• History of type 1 diabetes mellitus (T1DM), or diabetic ketoacidosis (DKA), or secondary forms of diabetes such as cystic fibrosis

• Known hypersensitivity or allergy to insulin-glargine or its excipients or any other insulins

• Two or more severe hypoglycemic episodes within the prior year

• Hypoglycemia unawareness defined by history

• History of proliferative diabetic retinopathy

• Is currently unstable and/or has moderate-to-severe medical illness in the Investigator's judgment

• Uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure = 160 mmHg or a diastolic blood pressure = 100 mmHg at screening

• History of recent major surgery within 6 months, or minor surgery within 3 months (such as appendectomy) prior to screening visit, or a planned surgery during the study period

• History of bariatric surgery

• Active chronic infections

• Women of child-bearing age who are pregnant, planning pregnancy, breast-feeding, or, if capable of pregnancy, are not practicing contraception if heterosexually active

• Known hypersensitivity to plastics/polymers/adhesives

• Known difficulties with adherence of adhesives, bandages, or dressings

• Participated in any research study within the past 30 days

• Currently participating in another investigational trial

• Use of short term or chronic systemic steroids within three months of entry into the study or likelihood that same might be required during the conduct of the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Bolus Insulin Patch (Calibra Finesse)

• Insulin Pen (Novo-Nordisk FlexPen®)

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny
France	Hopital Saint-Andre	Bordeaux
France	Hopital Hotel-Dieu Site Harfleur	Le Creusot
France	Lapeyronie Hospital, University Hospital Montpellier	Montpellier cedex 5
France	Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications	Paris
France	CHU de Nantes-Hospital Nord Laennec	Saint-Herblain
France	GHMP les Portes du Sud	Venissieux
Germany	Diabeteszentrum DO-Diabetologisch	Dortmund
Germany	BAG Unterm Heilig Kreuz Unterm Heilig Kreuz	Fulda
Germany	Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.	Mainz
United Kingdom	Royal United Hospital, Diabetes & Lipid Research Wolfson Centre	Bath
United Kingdom	Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust	Blackburn
United Kingdom	Chorley and South Ribble Hospital	Chorley
United Kingdom	Ninewells Hospital & Medical School Diabetes Support Unit	Dundee
United Kingdom	Forth Valley Royal Hospital Dept. of Diabetes	Larbert
United Kingdom	Leicester General Hospital Leicester Diabetes Centre	Leicester
United Kingdom	Royal Liverpool University Hospital	Liverpool
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes & Endocrinology, P.A.- Austin	Austin	Texas
United States	Progressive Clinical Research	Bountiful	Utah
United States	University Diabetes and Endocrine Consultants	Chattanooga	Tennessee
United States	John H. Stroger, Jr. Hospital of Cook County Diabetes Center	Chicago	Illinois
United States	Northwestern University The Feinberg School of Medicine	Chicago	Illinois
United States	VA Medical Center Cleveland	Cleveland	Ohio
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Baylor Endocrine Center	Dallas	Texas
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	Danville Internal Medicine	Danville	Virginia
United States	Denver VA Medical Center	Denver	Colorado
United States	Iowa Diabetes and Endocrinology Research Center	Des Moines	Iowa
United States	Henry Ford Health System	Detroit	Michigan
United States	Advanced Metabolic Care & Research Institute, Inc. (AMCR)	Escondido	California
United States	Private Practice-Larry Stonesifer	Federal Way	Washington
United States	Marin Endocrine Care and Research	Greenbrae	California
United States	Medstar Health Research Institute	Hyattsville	Maryland
United States	Rocky Mountain Diabetes and Osteoporosis Center PA	Idaho Falls	Idaho
United States	Physicians Research Associates	Lawrenceville	Georgia
United States	Kentucky Diabetes Endocrinology Center	Lexington	Kentucky
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Park Nicollet Institute International Diabetes Center	Minneapolis	Minnesota
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine Research Solutions, Inc	Roswell	Georgia
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Consano Clinical Research	San Antonio	Texas
United States	Diabetes & Glandular Disease Clinic, P.A.	San Antonio	Texas
United States	South Texas Veterans Health Care System	San Antonio	Texas
United States	Diabetes Research Institute Mills-Peninsula Health Service	San Mateo	California
United States	Encompass Clinical Research	Spring Valley	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Great Plains Diabetes	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Calibra Medical, Inc.	Medpace, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Treatment Satisfaction From Baseline to Week 24	Change in treatment satisfaction with insulin delivery system from baseline to week 24 was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.	24 weeks
Other	Change in Quality of Life From Baseline to Week 24	Change in Diabetes-Specific Quality of Life (QOL), baseline to week 24. was assessed by self-report on the validated Diabetes Specific Quality of Life Survey. Scale is 0-100. Higher score is better.	24 weeks
Primary	Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy	Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy	24 weeks
Secondary	Number of Patients With A1C =7.0% at Week 24	Number of patients with A1C =7.0% at week 24	24 weeks
Secondary	Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24	Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients)	24 weeks
Secondary	Change in A1C From Baseline to Week 44	Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy	44 weeks
Secondary	Number of Patients With A1C =7.0% at Week 44	Number of patients with A1C =7.0% after 44 weeks of basal and bolus insulin therapy	44 weeks
Secondary	Change in A1C From Week 24 to Week 44	Change in A1C from week 24 to week 44 after basal and bolus insulin therapy	44 weeks
Secondary	Number of Participants With Severe Hypoglycemic Event	An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.	44 weeks